Systems and methods for controlling dual mode negative pressure wound therapy apparatus

ABSTRACT

In some embodiments, a negative pressure wound therapy device includes a negative pressure source and a controller configured to, in response to determining that the negative pressure source is directly fluidically connected to a wound dressing without a canister between the two, operate the negative pressure source in a first mode; otherwise, operate the negative pressure source in a second, different mode. The controller can be further configured to, in response to determining that a level of activity of the negative pressure source over a first time duration satisfies at least one of a leak or blockage condition, provide an indication of at least one of a leak or blockage and, in response to determining that the level of activity does not satisfy the at least one of the leak or blockage condition over a second time duration subsequent to the first time duration, discontinue providing the indication.

FIELD

Embodiments or arrangements disclosed herein relate to methods andapparatuses for dressing and treating a wound with topical negativepressure (TNP) therapy. For example, but without limitation, anyembodiments disclosed herein may relate to treating a wound with reducedpressure. As another non-limiting example, any of the embodimentsdisclosed herein may relate to apparatuses and methods for controllingthe operation of a TNP system.

DESCRIPTION OF RELATED ART

Many different types of wound dressings are known for aiding in thehealing process of a human or animal. These different types of wounddressings include many different types of materials and layers, forexample, pads such as gauze pads or foam pads. Topical negative pressure(“TNP”) therapy, sometimes referred to as vacuum assisted closure,negative pressure wound therapy, or reduced pressure wound therapy, iswidely recognized as a beneficial mechanism for improving the healingrate of a wound. Such therapy is applicable to a broad range of woundssuch as incisional wounds, open wounds and abdominal wounds or the like.

TNP therapy assists in the closure and healing of wounds by reducingtissue edema; encouraging blood flow; stimulating the formation ofgranulation tissue; removing excess exudates, and may reduce bacterialload and thus reduce the potential for infection of the wound.Furthermore, TNP therapy permits less outside disturbance of the woundand promotes more rapid healing.

SUMMARY

In some embodiments, a negative pressure wound therapy device includes anegative pressure source configured to provide negative pressure to awound via a fluid flow path including a wound dressing positioned overthe wound and a controller configured to operate the negative pressuresource to provide negative pressure to the wound when the negativepressure source is fluidically connected to the wound dressing directlyor when the negative pressure source is fluidically connected to thewound dressing via a canister configured to store at least some fluidaspirated from the wound by the negative pressure source. The controllercan be further configured to: in response to determining that thenegative pressure source is directly fluidically connected to the wounddressing, operate the negative pressure source in a first mode toprovide negative pressure to the wound; in response to determining thatthe negative pressure source is fluidically connected to the wounddressing via the canister, operate the negative pressure source in asecond mode to provide negative pressure to the wound, the second modebeing different from the first mode; determine a level of activity ofthe negative pressure source; in response to determining that the levelof activity of the negative pressure source over a first duration oftime satisfies at least one of a leak condition or a blockage condition,provide a first indication of at least one of a leak or a blockage inthe fluid flow path after expiration of the first duration of time; andin response to determining that the level of activity of the negativepressure source does not satisfy the at least one of the leak conditionor the blockage condition over a second duration of time subsequent tothe first duration of time, discontinue provision of the firstindication of the at least one of the leak or the blockage in the fluidflow path after expiration of the second duration of time.

In certain embodiments, the apparatus of preceding paragraph can includeone or more of the following features. The second duration of time canbe shorter than the first duration of time. The level of activity of thenegative pressure source can include duty cycle of the negative pressuresource. At least one of the leak condition or the blockage condition caninclude a first duty cycle threshold in the first mode and a second dutycycle threshold in the second mode, the first duty cycle thresholddifferent from the second duty cycle threshold. The controller can befurther configured to compare the level of activity over the first andsecond durations of time to one of the first or second duty cyclethresholds. The first duty cycle threshold can be greater than thesecond duty cycle threshold.

In some implementations, the apparatus of any of preceding paragraphscan include one or more of the following features. The controller can befurther configured to provide the first indication of the at least oneof the leak or blockage in the fluid flow path without deactivating thenegative pressure source. In response to determining that the level ofactivity of the negative pressure source continues to satisfy the atleast one of the leak condition or the blockage condition over a thirdduration of time subsequent to the first duration of time, thecontroller can be configured to deactivate the negative pressure sourceafter expiration of the third duration of time. The controller can befurther configured to provide a second indication different from thefirst indication after expiration of the third duration of time. Thefirst indication can include a visual indication of a first color andthe second indication can include a visual indication of a second colordifferent from the first color. The third duration of time can besubsequent to the second duration of time.

In some embodiments, a method of using or operating the device havingany combination of features described in one or more precedingparagraphs is provided.

In certain embodiments, a method operating a negative pressure woundtherapy device including a negative pressure source and a controllerincludes, by the controller: operating the negative pressure sourceconfigured to provide negative pressure to a wound via a fluid flow pathcomprising a wound dressing positioned over the wound when the negativepressure source is fluidically connected to the wound dressing directlyor when the negative pressure source is fluidically connected to thewound dressing via a canister configured to store at least some fluidaspirated from the wound by the negative pressure source; in response todetermining that the negative pressure source is directly fluidicallyconnected to the wound dressing, operating the negative pressure sourcein a first mode to provide negative pressure to the wound; in responseto determining that the negative pressure source is fluidicallyconnected to the wound dressing via the canister, operating the negativepressure source in a second mode to provide negative pressure to thewound, the second mode being different from the first mode; determininga level of activity of the negative pressure source; in response todetermining that the level of activity of the negative pressure sourceover a first duration of time satisfies at least one of a leak conditionor a blockage condition, providing a first indication of at least one ofa leak or a blockage in the fluid flow path after expiration of thefirst duration of time; and in response to determining that the level ofactivity of the negative pressure source does not satisfy the at leastone of the leak condition or the blockage condition over a secondduration of time subsequent to the first duration of time, discontinuingprovision of the first indication of the at least one of the leak or theblockage in the fluid flow path after expiration of the second durationof time.

In some implementations, the method of preceding paragraph can includeone or more of the following features. The second duration of time canbe shorter than the first duration of time. The level of activity of thenegative pressure source can include duty cycle of the negative pressuresource. At least one of the leak condition or the blockage conditioncomprises a first duty cycle threshold in the first mode and a secondduty cycle threshold in the second mode, the first duty cycle thresholddifferent from the second duty cycle threshold. The method can furtherinclude, by the controller, comparing the level of activity over thefirst and second durations of time to one of the first or second dutycycle thresholds. The first duty cycle threshold can be greater than thesecond duty cycle threshold.

In certain embodiments, the method of any of preceding paragraphs caninclude one or more of the following features. The method can include,by the controller, providing the first indication of the at least one ofthe leak or blockage in the fluid flow path without deactivating thenegative pressure source, and in response to determining that the levelof activity of the negative pressure source continues to satisfy the atleast one of the leak condition or the blockage condition over a thirdduration of time subsequent to the first duration of time, deactivatingthe negative pressure source after expiration of the third duration oftime. The method can include, by the controller, providing a secondindication different from the first indication after expiration of thethird duration of time. The first indication can include a visualindication of a first color and the second indication comprises a visualindication of a second color different from the first color. The thirdduration of time can be subsequent to the second duration of time.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present disclosure will be apparentfrom the following detailed description, taken in conjunction with theaccompanying drawings of which:

FIG. 1 illustrates a reduced pressure wound therapy system including apump assembly according to some embodiments;

FIG. 2A illustrates a dual mode reduced pressure wound therapy systemoperating in a canisterless mode of operation according to someembodiments;

FIG. 2B illustrates a dual mode reduced pressure wound therapy systemoperating in a canister mode of operation according to some embodiments;

FIGS. 3A and 3B illustrate a dual mode reduced pressure wound therapyapparatus according to some embodiments;

FIGS. 4A and 4B illustrate a dual mode reduced pressure wound therapyapparatus according to some embodiments;

FIG. 5 illustrates a process for controlling the dual mode reducedpressure wound therapy apparatus according to some embodiments;

FIGS. 6A-6D illustrate detection and indication of a leak or blockagecondition according to some embodiments;

FIG. 7 illustrates a flowchart of blockage and leak detection andindication according to some embodiments; and

FIGS. 8A and 8B illustrate escalation of blockage and leak alertsaccording to some embodiments.

DETAILED DESCRIPTION Overview

Embodiments disclosed in this section or elsewhere in this specificationrelate to apparatuses and methods of treating a wound with reducedpressure, including pump and wound dressing components and apparatuses.The apparatuses and components comprising the wound overlay and packingmaterials, if any, are sometimes collectively referred to in thissection or elsewhere in this specification as dressings.

It will be appreciated that throughout this specification reference ismade to a wound. It is to be understood that the term wound is to bebroadly construed and encompasses open and closed wounds in which skinis torn, cut or punctured or where trauma causes a contusion, or anyother superficial or other conditions or imperfections on the skin of apatient or otherwise that benefit from reduced pressure treatment. Awound is thus broadly defined as any damaged region of tissue wherefluid may or may not be produced. Examples of such wounds include, butare not limited to, abdominal wounds or other large or incisionalwounds, either as a result of surgery, trauma, sterniotomies,fasciotomies, or other conditions, dehisced wounds, acute wounds,chronic wounds, subacute and dehisced wounds, traumatic wounds, flapsand skin grafts, lacerations, abrasions, contusions, burns, electricalburns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, traumaand venous ulcers or the like.

Embodiments of the present disclosure are generally applicable to use intopical negative pressure (TNP) or reduced pressure therapy systems.Briefly, negative pressure wound therapy assists in the closure andhealing of many forms of “hard to heal” wounds by reducing tissue edema,encouraging blood flow and granular tissue formation, or removing excessexudate and can reduce bacterial load (and thus infection risk). Inaddition, the therapy allows for less disturbance of a wound leading tomore rapid healing. TNP therapy systems can also assist in the healingof surgically closed wounds by removing fluid. In some embodiments, TNPtherapy helps to stabilize the tissue in the apposed position ofclosure. A further beneficial use of TNP therapy can be found in graftsand flaps where removal of excess fluid is important and close proximityof the graft to tissue is required in order to ensure tissue viability.

Dual Mode Negative Pressure System

FIG. 1 illustrates a negative or reduced pressure wound treatment (orTNP) system 100 according to some embodiments. The system 100 comprisesa wound filler 130 placed inside a wound cavity 110, the wound cavity110 sealed by a wound cover 120. In some embodiments, one or more of thewound filler 130, the wound cover 120, or any other component, such as acontact layer (not shown), make up a wound dressing. The system 100includes a negative pressure wound therapy device, apparatus, or a pumpassembly 150 configured to provide reduced pressure to the wound. Forexample, a conduit 140 having at least one lumen can provide a fluidflow path between the pump assembly 150 and the wound.

FIGS. 2A-2B illustrate that the reduced pressure wound therapy systemcan be configured to operate with and without a canister (for example,in canister and canisterless modes) according to some embodiments. FIG.2A shows an embodiment of the TNP system 200A that has a wound dressingconnected directly to the pump assembly 150 (for example, canisterlessmode). FIG. 2B shows an embodiment of the TNP system 200B that has acanister 230 interposed between the wound dressing and the pump assembly150 (for example, canister mode). At the beginning of the application ofnegative pressure wound therapy to a wound when the wound is in theearly stages of the healing process and exudes a significant volume ofexudate, the reduced pressure wound therapy system may operate with acanister. In this mode of operation, the negative pressure wound therapysystem may operate with a foam or gauze RENASYS™ dressing sold by Smith& Nephew or any other suitable dressing. Operation of the reducedpressure wound therapy system with a canister may sometimes be referredto herein as “RENASYS”, “RENASYS-mode”, or derivatives thereof. As thewound is progressing through the healing process and is starting toexude a smaller volume of exudate, the canister may be removed and thenegative pressure wound therapy system may operate with an absorbentdressing, such as the PICO™ dressing sold by Smith & Nephew or any othersuitable dressing that retains the wound exudate within the dressing.Operation of the reduced pressure wound therapy system without acanister may sometimes be referred to herein as “PICO”, “PICO-mode”, orderivatives thereof.

The pump assembly 150 can include one or more switches or buttons 202,one or more indicators 204, and a control board 206, which can includeone or more controllers, one or more memories, or the like. The one ormore buttons 202 and the one or more indicators 204 (which collectivelymake up a user interface) can be in electrical communication with thecontrol board 206, which can include one or more controllers and memory.The one or more buttons 202 can be used for any suitable purpose forcontrolling an operation of the pump assembly 150. For example, the oneor more buttons 202 can be used to activate the pump system 150, pausethe pump assembly 150, and clear system indicators such as one or moreof the one or more indications 204. The one or more buttons 202 can byany type of switch or button, such as a touchpad, touch screen,keyboard, and so on. In some embodiments, the one or more buttons 202can be a press button. In various implementations, one or more buttons202 can be included on a touchscreen interface.

The pump assembly 150 can include a connector port 203 adapted toreceive a connector 201. The connector 201 can be a part of the canisteror the wound dressing that is attached to the pump assembly 150, asdescribed herein. The connector 201 can be removably attached to theconnector port 203. In some arrangements, a first connector 201 can beremoved from the pump assembly 150 and replaced with a second connector201 that is then attached to the pump assembly 150. For example, a firstconnector 201 that is connected to a RENASYS™ dressing can be removedfrom the connector port 203 and replaced with a second connector 201that connected to a PICO™ dressing, thereby allowing the pump assembly150 to be switched from canister to a canisterless mode of operation. Asdescribed in more detail below, the connector 201 and/or pump assembly150 can be adapted to allow the pump assembly 150 to detect whether acanister or canisterless connector 201 is attached to the connector port203. In some arrangements, the operation of the pump assembly 150 can beadjusted according to whether the pump assembly 150 detects a canisteror a canisterless connector 201 is connected to the connector port 203.

In some embodiments, the connector port 203 can include one or moreconnector switches in electrical communication with the control board206, which can include one or more controllers. The one or moreconnector switches can be configured to engage one or more connectors ofthe canister or the dressing. In some embodiments, the one or moreconnector switches can advantageously permit the pump assembly 150(e.g., the control board 206) to differentiate between a canisterconnection and a dressing connection. In some embodiments, one or moreof the connectors 201 can include one or more connector switches inaddition to or in lieu of the one or more connector switches of theconnector port 203. The connector switches contemplated herein can bemechanical, electrical, optical, and/or magnetic, or any other suitableswitch, and can include sensors and the like. The connector switches canbe configured to close or open an electrical circuit, thereby permittingthe control board 206 to detect whether the connector switch is engagedor disengaged. For example, as described in more detail below, theconnector port 203 can include a connector switch that is actuated by aportion of a connector 201 that couples a canister to the connector port203. The connector switch can be further configured so that the switchis not actuated by a connector 201 that couples a dressing to theconnector port 203, thereby allowing the control board 206 to detectwhether a canister or a dressing is attached to the connector port 203.In some arrangements, the pump assembly 150 can be configured so thatthe connector switch is activated by a connector 201 that couples adressing to the connector port 203 and is not activated by a connector201 that couples a canister to the connector port 203.

With continued reference to FIG. 2A, the one or more indicators 204 canindicate one or more operating or failure conditions of the pumpassembly 150. Each of the one or more indicators 204 may provide anindication regarding a different operating or failure condition. In someimplementations, an active (such as, lit) visual indicator (such as,LED) of the one or more indicators 204 can represent a certain operationcondition for the pump assembly 150. For example, a dressing indicatorof the one or more indicators 204 can provide an indication as topresence of leakages or leaks in the TNP system 100, and an activedressing indicator can represent a leak. As another example, a dressingcapacity indicator of the one or more indicators 204 can provide anindication as to the remaining fluid capacity of the wound dressing orcanister, and an active dressing capacity indicator can represent thatthe wound dressing or canister is at or nearing capacity. As yet anotherexample, a power source indicator of the one or more indicators 204 canprovide an indication as to remaining capacity or life of the powersource 208, such as one or more batteries, and an active power sourceindicator can represent a low capacity. In some embodiments, the one ormore indicators 204 can represent a combination of one or more of theabove operating or failure conditions of the pump assembly 150 or otheroperating or failure conditions for the pump assembly 150.

In some implementations, the one or more indicators 204 can be icons.For example, the one or more indicators 204 can be activated (e.g., lit)via an illumination source such as LEDs (not shown) of pump assembly150. The one or more indicators 204 can, for instance, be of a differentcolor, two different colors (e.g., two indicators can share the samecolor), or same color. In some embodiments, the pump assembly 150 caninclude visual, audible, tactile, haptic, or other types of indicatorsor alarms configured to signal to the user various operating conditions.Such conditions include system on/off, standby, pause, normal operation,dressing problem, leak, error, and the like. The indicators can includespeakers, displays, light sources, etc., or combinations thereof. Invarious implementations, one or more buttons indicators 204 can beincluded on a touchscreen interface.

The pump assembly 150 can be powered by a power source 208 such as a oneor more battery cells or any other suitable power source. Battery cellscan include any combination of one or more of lithium-ion,lithium-polymer, lithium iron phosphate, lead acid, nickel based,alkaline, or the like. The pump assembly 150 can also include a sourceof negative pressure 210, which can include a pump 212 powered by anactuator 214, such as an electric motor. In some embodiments, theactuator 214 is integrated into the pump 212. The negative pressuresource 210 can be a rotary diaphragm pump or other diaphragm pump, apiezoelectric pump, a peristaltic pump, a piston pump, a rotary vanepump, a liquid ring pump, a scroll pump, a diaphragm pump operated by apiezoelectric transducer, a pump operated by a voice coil actuator, orany other suitable pump or micropump or any combinations of theforegoing, The pump assembly 150 can also include one or more pressuresensors 216 that measure pressure in the fluid flow path. The powersource 208 can supply power to electro-mechanical components of the pumpassembly 150, including one or more of the negative pressure source 210,pressure sensor 216, control board 206, buttons 202, and indicators 204.

The pump assembly 150 can further include an inlet 218 to connect thepump assembly 150 to the wound dressing. For example, the inlet 218 canbe connected to the connector port 203 and the connector 201 that is influid communication with the wound dressing via a fluid flow path.

The pump assembly 150 can also include an outlet 220. The outlet 220 canvent or exhaust gas to the atmosphere. In some embodiments, a filter(not shown) can be interposed between the outlet 220 and the atmosphere.The filter can provide filtration of the gas prior to venting the gas tothe atmosphere. The filter can be a bacterial filter, odor filter, orany combination thereof. In some embodiments, a dampening component (notshown), such as a noise dampening component, can be interposed betweenthe outlet 220 and the atmosphere. The dampening component can reducethe noise generated by the pump assembly 150 during operation. In someimplementations, the pump assembly 150 can communicate information, suchas information related to provision of negative pressure therapy, to oneor more remote devices. Such communication can be performed using awired or wireless interface.

FIG. 2B illustrates the pump assembly 150 of FIG. 2A with a canister 230additionally positioned in a fluid flow path between the inlet 218 andthe wound dressing. In the illustrated embodiment, the connector 201fluidically connects the canister 230 to the connector port 203. Asdiscussed further below, the connector 201 can be configured to signalto the pump assembly 150 whether the connector port 203 is connected toa wound dressing directly or whether a canister 230 is disposed betweenthe connector 203 and the wound dressing.

In some embodiments, the control board 206 (for example, a controller)adjusts one or more operational parameters of negative pressure woundtherapy depending on whether the pump assembly is connected to thecanister or the dressing. For example, in canisterless mode, the levelof negative pressure provided to the wound can be reduced compared tocanister mode because the wound is exuding a smaller amount of fluid. Asanother example, detection of one or more operating conditions can beenabled, disabled, or adjusted. For instance, in canisterless mode,canister full detection (or blockage detection) and alarming can bedisabled and, instead, dressing full detection and alarming can beenabled.

In some embodiments, the pump assembly 150 includes a user interface,such as one or more displays, indicators, lights, buttons, switches,speakers, vibrating elements, etc. The user interface can be adjustedbased on detection of a canister. For example, in canister mode, theuser interface can include an indicator alerting a user when canisterbecomes full. In canisterless mode, this indicator can be replaced withan indicator alerting the user when the dressing become full. In someembodiments, the indicators are icons.

FIG. 3A depicts a perspective view 300A of an embodiment of a dual modeTNP system in a canister mode according to some embodiments. In theillustrated system, a canister 160G is attached to a pump assembly 150G(which can be similar as the pump assembly 150 described herein). Thepump assembly 150G can be adapted to be slidably coupled to the canister160G. The canister 160G can have an inlet 161G through which woundexudate can enter the canister 160G. In some embodiments, the pumpassembly 150G may slide back to disengage the pump assembly 150G fromthe canister 160G, as illustrated with respect to FIG. 3B.

FIG. 3B depicts a perspective view 300B of an embodiment of the TNPsystem with the canister 160G disengaged from the pump assembly 150Gaccording to some embodiments. In some cases, the pump assembly 150G canoperate in a canisterless mode. As described above, the pump assembly150G can have a connector port 203G that is adapted to connect to aconnector 201 (shown schematically in FIGS. 2A-2B). The connector 201can be a canister connector or a canisterless connector as discussedherein. The connector port 203G can be fluidically connected to anegative pressure source (such as, vacuum pump) housed within the pumpassembly 150G. The connector port 203G can establish a flow path betweenthe negative pressure source of the pump assembly 150G and the connector201 that is connected to the connector port 203G. The pump assembly 150Gcan provide negative pressure to a canister connector 260G or acanisterless connector that is attached to the connector port 203G. Thecanister 160G can have the canister connector 260G that fluidicallyconnects to the connector port 203G when the pump assembly 150G isslidably mounted onto the canister 160G. Mounting (such as slidinglymounting) the canister 160G can activate a switch configured to indicatethat the canister has been connected, as described herein. Conversely,dismounting of the canister 160G can deactivate the switch. The canister160G can have an inlet 161G through which wound exudate enters thecanister 160G when negative pressure is applied to the canister 160Gthrough the canister connector 260G.

With continued reference to FIGS. 3A-3B, the pump assembly 150G caninclude a dial 327G (also illustrated in FIGS. 4A-4B) that allowspressure selection on the pump assembly 150G. The magnitude of thenegative pressure supplied by the pump assembly 150G can be adjusted byturning the dial 327G. The dial 327G can be adapted to turn to two ormore discreet settings. For example, the dial 327G can have threediscreet settings that allow the negative pressure provided by the pumpassembly 150G to be set to one of three settings (e.g., −60 mmHg, −80mmHg, and −120 mmHg). The pump assembly 150G can include a bar 159G thatcan be used as an anchoring site for a strap or clasp, thereby allowingthe pump assembly 150G to be suspended from a strap that is attached tothe bar 159G. When the canister 160G and the pump assembly 150G areconnected together, a ramped portion of the top surface of the canister160G can form an overhang that is supported on an inclined portion ofthe bottom surface of the pump assembly 150G, thereby enhancingretention of the canister 160G on the pump assembly 150G when the pumpassembly 150G is suspended from the bar 159G. The pump assembly 150G caninclude one or more icons on the housing 153G of the pump assembly 150G.The icons can be backlit by a light source that is disposed within thehousing 153G of the pump assembly 150G.

Operating Dual Mode Negative Pressure System

In some embodiments, a dual mode TNP system of any of the embodimentsdisclosed herein, including a system illustrated in FIGS. 4A and 4B, canbe operated or used by a user, such as clinician and/or patient. Inparticular, use of the TNP system can begin with the assessment of apatient and the wound to be treated. This may be followed by the initialselection of canister or canisterless mode of treatment and dressing orcanister size to be used in the selected mode. For example, small ormedium foam or medium gauze dressing can be used in canister mode. Asanother example, small (approximately 10×20 cm), medium (approximately15×15 cm), or large (approximately 20×20 cm) multi-layer absorbentdressing can be used in canisterless mode.

The operating mode can be changed at any time during use when clinicallyappropriate, such as switching from canister mode to canisterless modeafter the wound has sufficiently healed to exude lower volume of fluid,which can be managed by the absorbent dressing. Switching from canisterto canisterless mode can include turning off the source of negativepressure, removing the canister and dressing, applying appropriatedifferent dressing and connecting the dressing to the source of negativepressure, and turning on the source of negative pressure to restarttherapy. Switching from canisterless to canister mode can includeturning off the source of negative pressure, removing the dressing,applying appropriate different dressing, selecting a target negativepressure level or setpoint, attaching the canister and connecting thedressing to the canister, and turning on the source of negative pressureto restart therapy. The TNP system can automatically detect which modeit is operating in.

In some cases, the target negative pressure setpoint can be selectedonly in canister mode. For example, in canister mode, the setpoint canbe selected as −60 mmHg, −80 mmHg, −120 mmHg as described herein. Thesetpoint can be selected using the dial or switch as described herein.In some implementations, additional or alternative setpoint values canbe used. In canisterless mode, the setpoint can be preset to a suitablenegative pressure, such as −80 mmHg.

Optional carry strap can be attached to the TNP device. For example, thecarry strap can be attached through one or more slots in the devicehousing. Length of the strap can be adjusted as needed. The device canbe positioned upright or hung from the strap.

If canister mode is desired, the canister can be installed, for example,by being slid onto the TNP device described herein (which can activatean electromechanical switch configured to indicate canister mode ofoperation). The dressing can be connected to the canister. For example,the dressing can be connected using a quick-click connector, luerconnector, or the like. As described herein, the dressing can beconnected to the canister inlet, such as the inlet 161G.

In canisterless mode a dressing can be connected to the TNP device. Forexample, the dressing can be connected to a connector port of thedevice, such as the connector port 203G. The dressing can be connectedusing a luer connector, quick-click connector, or the like. After thedressing has been properly connected, provision of TNP therapy can beinitiated. For example, the user can activate a switch, such as switch430 illustrated in FIGS. 4A-4B. In some cases, the user can slide theswitch, press the switch or the like to activate the negative pressuresource. The device can provide an indication that therapy is active, forexample, by flashing an indicator 418 illustrated in FIGS. 4A-4B anddescribed herein. The device can provide an indication that the negativepressure setpoint has been reached. For example, the indicator 418 canstop flashing and turn to a solid color as described herein.

At any time, provision of TNP therapy could be paused or stopped.Therapy can be paused by operating the switch as described herein. Forexample, TNP therapy can be paused to change the canister. The canistermay be changed at least once a week or sooner if the canister is full ornearly full. As another example, TNP therapy can be paused to change thedressing when it is full or nearly full. As yet another example, TNPtherapy can be paused so that the user can shower.

The canister can be changed or replaced by disconnecting it from thewound dressing and removing the canister, both of which can be performedas described herein. The removed canister can be disposed of and newcanister can be installed, as described herein. Dressing can be changedor replaced by removing it, disposing it, and applying a new dressing,as described herein. Provision of therapy can be restarted uponreplacement of the canister or dressing as described herein,

Power source, such as battery, may need to be periodically recharged. Insome cases, the device can indicate via an indicator 412 illustrated inFIGS. 4A-4B that the power source is low or critically low. For example,indicator 412 can turn solid when the power source is low or flash whenthe power source is critically low. Device can continue to operate whilethe power source is being charged. Charging can be indicated via anindicator. Completion of charging can be indicated via the indicator.

Various checks of the TNP system may be performed during provision ofTNP therapy. Canister or dressing may need to periodically checked andreplaced as described herein.

During operation or use, the TNP system can provide various indicationsto the user. The indications can relate to one or more of power levels,charging, provision of therapy, presence of one or more leaks in a fluidflow path, presence of one or more blockages in the fluid flow path,reaching end of life (for example, 30 days), or the like. Theindications can be one or more of visible, such as via one or more LEDs,audible, haptic, tactile, or the like. For example, FIGS. 4A and 4Billustrate various visual indicators on a housing of the pump assembly150, including 412 (battery level), 414 (blockage), 416 (leak), and 418(power or provision of therapy) in canisterless (FIG. 4A) and canister(FIG. 4B) modes of operation. FIG. 4B also illustrates the pump assembly150 connected to a canister 160.

The illustrated indicators can be configured to provide variousindications, such as described herein. Certain indications can benon-critical alarms that do not result in pausing therapy, while certainindications can be critical alarms that result in pausing or stoppingtherapy. For example, as described herein, detection of a minor orsustainable air leak can be a non-critical alarm that does not result inpausing therapy, whereas detection of a major or unsustainable air leakcan be a critical alarm that results in pausing therapy.

Various indications and corresponding user actions can be provided viathe indicator 412 as detailed in the following table.

Appearance Status Action

SOLID AMBER Low power source. Charge power source, for example, within 3hours.

FLASHING AMBER Critically low power source. Charge power sourceimmediately.

Various indications and corresponding user actions can be provided viathe indicator 414 as detailed in the following table.

Appearance Status Action

SOLID AMBER There is a blockage in the system or the cansiter is fulland should be replaced. Therapy is impaired. Troubleshoot blockage/canister full.

FLASHING AMBER Device has detected a blockage over a period of time,such as 1 hour. Therpay has been paused. Therapy has been interrupted.Troubleshoot blockage/ canister full.Troubleshooting blockage/canister full can involve one or more ofchecking the conduit(s) for any kinks, changing the canister, orchanging the dressing.

Various indications and corresponding user actions can be provided viathe indicator 416 as detailed in the following table.

Appearance Status Action

SOLID AMBER There is a leak in the system. Therapy is impaired.Troubleshoot the leak.

FLASHING AMBER There is a major leak in the system. Therapy has beenpaused. Therapy has been interrupted. Troubleshoot the leak.Troubleshooting the leak can involve one or more of checking theconduit(s) for any leaks, smoothing out the dressing, or changing thedressing.

Various indications and corresponding user actions can be provided viathe indicator 418 as detailed in the following table.

Appearance Status Action

FLASHING GREEN Device is opearting to achive the negative pressuresetpoint. Wait unil indicator stops flashing.

SOLID GREEN Therapy is being delivered. None

FLASHING AMBER Therapy is no longer being delivered Troubleshoot alarmsas described herein. Restart therapy.

FLASHING GREEN & AMBER End-of-life is approaching. Device has a limitedperiod of time, such as 1 day, of therapy remaining. Obtain a differentdevice if needed.

Controlling Dual Mode Negative Pressure System

FIG. 5 illustrates a process 500 for controlling the dual mode reducedpressure wound therapy apparatus according to some embodiments. Theprocess 500, which can also be referred to as a state machine, can beexecuted by one or more controllers of the TNP system, such as thesystem 100. The process 500 includes Power Off State 502, Power OnStates 504, and Soft Power Off State 522. Power On States 504 caninclude Entry State 506, Self Testing State 508, Non-Recoverable Error(NRE) State 510, Therapy Active States 512, and Therapy Stop State 520.The Therapy Active States 512 can further include Therapy InitializationState 514, Pump Down State 516, and Maintain Pressure State 518.

In some embodiments, operation of the TNP system starts in the Power OffState 502, and the process 500 can transition to the Power On States504. This transition can be made automatically or in response to a useraction, such as in response to a press of an “On” button (for example,one of the buttons 202). The process 500 can transition to the Power OnStates 504 from Power Off State 502 upon a system reset, which can beperformed by the user through one or more of the buttons 202. Suchsystem reset can involve a reset of the one or more controllers.

In some embodiments, the process 500 transitions to the Power On States504 in response to waking up from the Soft Power Off State 522. In theSoft Power Off State 522, the process 500 can be operating in low powermode, such as by causing the one or more processors to sleep orotherwise consume little power. This transition can be performedautomatically, such as after passage of a duration of time.Alternatively or additionally, this transition can be performed inresponse to a user action as described herein. When the process 500 isin the Soft Power Off State 522, the TNP system may be off and notprovide negative pressure.

The process 500 can enter the Power On States 504 via the Entry State506 as illustrated in FIG. 5. The Power On States 504 can include foursub-states: Self-Testing State 508, Therapy Active States 512, TherapyStop State 520, and Non-recoverable Error State 510.

Upon transition to the Power On States 504, the process 500 can monitoror continue monitoring power source capacity, such as battery voltage orcurrent. If the power source capacity falls below a certain thresholdassociated with proper operation of the TNP system, the process cantransition to the Soft Power Off State 522. The process 500 cantransition from the Power On States 504 to the Soft Power Off State 522in response to a user action, such as in response to a press of an “Off”button (for example, one of the buttons 202). In some cases, a singlebutton is configured to function as “On” and “Off” button.

Upon entering the Power On States 504, the process 500 can transitioninto Self-Test State 508. In the Self-Test State 508, the process 500can perform one or more of power-up self-tests (POSTs) to verify thatthe TNP system is operating properly. For example, the process 500 canvalidate memory, verify that the TNP system has not reached end-of-life(EOL) (as explained herein), verify calibration values, or the like. Insome cases, validation of memory can utilize Cyclic Redundancy Check(CRC). For example, the process 500 can calculate CRC value on at leasta portion of data stored in the memory, compare the calculated CRC valueagainst stored CRC value, and determine if the two CRC values match.This determination can indicate that, for example, firmware of the TNPsystem 100 is functional and has not been tampered with. This can ensureproper administration of the negative pressure therapy. In someimplementations, checking the system's EOL status or calibration profileallows the process 500 to verify that quality of the negative pressuretherapy is not compromised. If one or more self-test fails, the process500 can transition into the Non-Recoverable Error State 510. The NonRecoverable Error State 510 can be a trap state that cannot be leftother than by switching off the power (which can cause the transition tothe Soft Power Off State 522). The Non Recoverable Error State 510 canalso be transitioned into when the process 500 determines that the TNPsystem has reached EOL from any state.

Upon passing POSTs, the process 500 can transition to the Therapy ActiveStates 512. In some cases, Therapy Active States 512 are entered via theTherapy Initialization State 514. Upon transitioning to the TherapyActive States 512, the process 500 can determine that the TNP system isoperating in canister or canisterless mode. For example, as describedherein, the process can determine that the switch indicating attachmentof a canister has been activated in order to determine that the TNPsystem is operating in the canister mode.

The process 500 can determine target pressure setpoint depending on themode of operation. In some cases, in canisterless mode, the targetpressure setpoint is preset. For example, the target pressure setpointin canisterless mode can be −80 mmHg. In some cases, in canisterlessmode, the target pressure setpoint can be selected. For example, thetarget pressure setpoint can be selected using the dial 327G asdescribed herein. For instance, in canister mode, the target pressuresetpoint can be selected as −60 mmHg, −80 mmHg, or −120 mmHg. In somecases, the target pressure setpoint can be set once by the process 500before negative pressure therapy is applied and can remain set until theTNP system has been powered-off and on again.

The process 500 can transition to the Pump Down State 516 in whichprovision of negative pressure wound therapy is commenced. The process500 can activate or start the negative pressure source to attempt toreduce pressure at the wound to the target pressure setpoint. Theprocess 500 can monitor pressure at the wound with one or more pressuresensors positioned in a fluid flow path connecting the negative pressuresource to the dressing. When the pressure has been successfully reducedto the target set point, the process 500 can transition to the MaintainPressure State 518. In some cases, the process 500 can stop ordeactivate the source of negative pressure when the target set point hasbeen reached or attained. In some cases, the process 500 can slow downthe source of negative pressure when the target set point has beenreached or attained.

In the Maintain Pressure State 518, the target pressure can bemaintained, for example, by activating the negative pressure source pumpwhen pressure at the wound has decreased above the target pressuresetpoint and deactivating the negative pressure source when the targetpressure has been restored. Pressure at the wound can decrease above thesetpoint (or become more positive) due to one or more leaks in the fluidflow path.

In both Pump Down State 516 and Maintain Pressure State 518, varioussystem parameters, such as pressure at the wound, level of activity ofthe negative pressure source, or the like, can be monitored to determinewhether negative pressure wound therapy should be stopped or additionalor alternative indication should be provided. Such additional oralternative indication can include the process 500 providing one or moreof visual (such as, using one or more indicators 204), audible, haptic,tactile, or the like indications. Such determination can be based onfinding of one or more blockages or leaks in the fluid flow path. Insome cases, level of activity of the negative pressure source can bemonitored via determining duty cycle of the negative pressure source,which can reflect proportion of time the negative pressure source isactive over a time duration. In some embodiments, as explained herein, atimeout mechanism (such as, monitoring the blockage or the leakduration) or determination scheme using a hysteresis can be used toreduce a likelihood of false positives in the blockage or the leakdetection.

In some cases, detection of a leak or blockage can cause the process 500to transition into the Therapy Stop State 520 from one or more of PumpDown 516 or Maintain Pressure 518 States. In this state, negativepressure source can be stopped to pause provision of therapy. Theprocess 500 can transition to the Therapy Stop State 520 in response todetecting: (1) pump down time indicative of a leak in canister orcanisterless mode, (2) timeout indicative of blockage while maintainingpressure in the canister mode, (3) timeout indicative of a leak whilemaintaining pressure in canister or canisterless mode, or the like.

In some embodiments, the process 500 can distinguish between sustainableand unsustainable leaks or blockages as described herein. For example, asustainable leak or blockage can be associated with less intensecondition(s) that do not necessitate pausing or stopping therapy.Rather, the process 500 can indicate presence of the sustainable leak orblockage as described herein to permit the user to remedy the leak orblockage without the necessity to interrupt therapy. As another example,an unsustainable leak or blockage can be associated with more intensecondition(s) that necessitate pausing or stopping therapy. Suchunsustainable conditions can be so severe that continuing operation ofthe negative pressure source to provide therapy can drain the capacityof the power source.

In some implementations, when the target pressure setpoint cannot bereached in the Pump Down State 516 over a duration of time, the process500 can determine presence of a leak. The process 500 can determine thatsuch leak that prevents reaching the setpoint is unsustainable andindicate its presence by stopping the negative pressure source.Additionally, the process 500 can indicate presence of the unsustainableleak visually, audibly, haptically, tactilely, or the like as describedherein. Unsustainable leaks can be due to, for example, disconnectingthe dressing from the negative pressure source when operating in thecanisterless mode or disconnecting the canister when operating in thecanister mode.

In some embodiments, the process 500 may not be able to restore thetarget pressure at the wound in the Maintain Pressure State 518 due topresence of a leak or blockage in the fluid flow path. The process 500can distinguish between leak or blockage by comparing the level ofactivity of the negative pressure source, such as the duty cycle, to aleak threshold or blockage threshold as described herein. When blockageis present, fluid flow path volume through which the negative pressuresource moves fluid is reduced. As a result, the level of activity of thenegative pressure source decreases. When leak is present, fluid flowpath volume through which the negative pressure source moves fluid isincreased. As a result, the level of activity of the negative pressuresource increases. By using different leak and blockage thresholds, theprocess 500 can distinguish between leak and blockage conditions. Leakand blockage thresholds can be selected or adjusted to account forcanister or canisterless modes of operation. This can be advantageousbecause of different fluid flow path volumes when operating in bothmodes. For example, the fluid flow path volumes when operating incanister mode includes additional volume of the canister, which is notpresent in the canisterless mode.

In some implementations, the process 500 monitors lifetime or usage timeof the TNP system. For example, the process 500 can only update thelifetime in the Therapy Active States 512. Lifetime can be measured astotal amount of time the negative pressure source has been active sinceinitial activation of the TNP system. In some implementations, theprocess 500 can start measuring or monitoring lifetime only after atherapy has been successfully provided for a threshold period of time,such as 1 minute, 5 minutes, 10 minutes, 20 minutes, 25 minutes or thelike. Successfully provision of therapy can correspond to being able toattain and maintain target pressure.

The process 500 can monitor the lifetime to determine when it the TNPsystem reaches end of life, such as 7 days of operation, 10 days ofoperation, 30 days of operation, or like. The process 500 can determinewhen the TNP system has reached or exceeded its expected therapyoperation life or EOL. When the process 500 detects that EOL has beenreached, ability of provide negative pressure wound therapy is disabled.One or more of visual, audible, haptic, tactile, or the like indicationscan be provided as described herein. In some cases, upon detecting EOL,the process 500 transitions to the Non-Recoverable Error State 510, inwhich provision of therapy is disabled.

In some implementations, the process 500 can perform an EOL check byusing or maintaining Real-Time Clock (RTC) and accumulated usage time.The accumulated usage time may be stored in persistent memory, such asan EEPROM. The process 500 can periodically update the accumulated usagetime using RTC. For example, for every 15 minutes as determined by RTC,the process 500 can add 15 minutes to the accumulated usage time.

The process 500 can perform EOL check in the Self Testing State 508 whenstarting or restarting therapy or periodically. In some embodiments, theEOL check may be performed upon a request by the processor in theSoft-Power Off State 522. The request will trigger the EOL checkasynchronously instead of waiting for a periodic EOL check event, andimmediately transition the system into Non-Recoverable Error State 510in response to determining that EOL has been reached

As described herein, the process 500 can determine and indicate presenceof one or more blockages or leaks in the fluid flow path. In someembodiments, the process 500 can make such determination from pressurein the fluid flow path and level of activity of the negative pressuresource. Level of activity can, for example, be determined by monitoringa duty cycle of the negative pressure source, which is associated with aproportion of time the negative pressure source is active over a timeduration. For example, if the negative pressure source is active for 50seconds over a duration of one minute, the process 500 can determinethat the duty cycle is 0.83 (50/60) or 83% (50/60*100%).

In some implementations, the duty cycle can be used to determinepresence of a blockage or leak. Generally, the negative pressure sourceshould not work too hard or too little, which can respectively translatedirectly to high pump or low duty cycle. When the negative pressuresource is working too hard (corresponding to a high duty), a presence ofa leak can be suspected as the negative pressure source is working extrahard to move more fluid than expected to attempt to reach the targetpressure setpoint. When the negative pressure source is working toolittle, a presence of a blockage can be suspected as the negativepressure source not working hard enough because is moves less fluid thanexpected to attempt to reach the target pressure setpoint. Thus, theprocess 500 can use one or more pump duty cycle thresholds forcomparison with the calculated pump duty cycles to determine whether theone or more thresholds have been satisfied and indicate a blockage orleak.

FIG. 6A is a diagram 6100 illustrating normal operation of a TNP system,such as the system 100, according to some embodiments. On the y-axis isthe negative pressure source, for example a pump, duty cycle. On thex-axis is time denominated in minutes. The measured or calculated pumpduty cycles (such as, 6106 and 6108) are plotted according to theirvalues. Along the Y-axis, a leak threshold 6102 and a blockage limitthreshold 6104 are presented. A leak condition can be detected when thepump is working harder than expected or desired, thus exceeding the leakthreshold 6102. Conversely, a blockage condition can be detected whenthe pump is working too little to maintain the target pressure setpoint,thus falling below the blockage threshold 6104. Leak or blockagethresholds can be different depending on canister or canisterless modeof operation. For example, the leak threshold can be higher in canistermode than in canisterless mode, such as 12% and 4% respectively. Thiscan be due to the TNP system being expected to move more fluid in thecanister mode. In some embodiments, the process 500 can detect blockageand leak conditions in the canister mode, but only the leak condition inthe canisterless mode.

In FIG. 6A, as none of the pump duty cycles are above the threshold 6102or below the threshold 6104, the TNP system is operating normally. Theprocess 500 can remain in the Therapy Active States 512.

In some embodiments, the process 500 can implement hysteresis whendetecting blockage or leak. This can be performed to reduce the risk ofa false positive determination, which can lead to an incorrecttransition to the Therapy Stop State 520. Such false positivedetermination could be due to a temporary leak or blockage.

FIG. 6B is a diagram 6200 illustrating detection and indication of aleak condition according to some embodiments. As illustrated, the pumpduty cycles are continuously increasing and start to exceed the leakthreshold 6102. When the pump duty cycle exceeds the leak limitthreshold 6202, the process 500 can, instead of immediately providingindication of a leak, implement hysteresis. For example, after theinitial duty cycle 6202 above the leak threshold 6102, the process 500tracks the next pump duty cycle reading 6204 to determine that it alsoexceeds the threshold 6102. The process 500 can keep track of pump dutycycle readings that exceed the threshold 6102 (the count of such pumpduty cycle readings exceeding the threshold 6102 is shown in the diagram6200, for example, “2” is embedded in the second pump duty cycle reading6204). The process 500 can keep a counter that is incremented with eachconsecutive or non-consecutive duty cycle reading exceeding thethreshold 6102. The process 500 can indicate presence of a leak when thecounter reaches a threshold, such as 10 as illustrated in FIG. 6B withthe pump duty cycle 6206. As is shown, consecutive pump duty cycles werecounted over a 10 minute interval.

The process 500 can provide a leak indication, alarm, or alert when thethreshold is reached with the pump duty cycle 6206. As described herein,such alert can include one or more of visual, audible, tactile, hapticor the like alerts. The alert can provide an indication to the user toaddress the leak before stopping the therapy. For example, the processcan provide a duration of time to address the leak. During this time,the process 500 can continue to increment the counter for each pump dutycycle sample indicative of the leak condition. For example, FIG. 6Billustrates that the pump duty cycle 6208 counts it as 11 th pump dutycycle exceeding the leak threshold 6102. The duration of time for theuser to address the leak can be shorter than the duration of time fordetecting the leak. For example, the respective durations illustrated inFIG. 6B are 10 minutes for detecting the leak and 5 minutes foraddressing the leak.

When the process 500 determines that the leak condition has persistedbeyond the duration for addressing the leak, the process 500 can stopprovision of negative therapy. This can be performed to mitigatereduction of capacity of the power source, minimizing user discomfort(for example, due to noise from operating the negative pressure source),or the like. The process 500 can transition to the Therapy Stop State520. As shown in FIG. 6B, the process 500 can stop therapy afterdetermining that the duty cycle 6210 exceeds the leak threshold 6102.The process 500 can continue providing the same or provide differentindication or alert when therapy has been stopped.

In some embodiments, a measured pump duty cycle may greatly exceed theleak threshold 6102. For example, when one or more pump duty cycles areat or approximately 100% for a duration of time, this may indicate acatastrophic leak where the pump is working to its fullest but cannotattain the target pressure. Such catastrophic leaks are unsustainableand can compromise the effectiveness of a therapy or rapidly drain thepower source. For example, catastrophic leaks can occur as a result of aremoved dressing in canisterless mode, removed canister in canister mode(which can be detected via the switch), or disconnecting the negativepressure source from the fluid flow path in either mode. In thesescenarios, while the pump may work strenuously (such as, near 100% pumpduty cycle) to try to achieve the target pressure setpoint, but may notbe able to do so. As further described herein, the process 500 candetect catastrophic leak by determining that the pump operates at ornear 100% duty cycle over a time duration and, in response to thedetection, stop provision of negative pressure. The process 500 canprovide an alert as described herein.

FIG. 6C is a diagram 6300 illustrating detection of a leak conditionaccording to some embodiments. Here, unlike FIG. 6B, the leak conditionis fixed after the initial detection (for example, within 5 minutes). Asshown, after the 13th count caused by the pump duty cycle 6302 exceedingthe leak threshold 6102, the next pump duty cycle 6304 is below thethreshold 6102 due to the leak being fixed. The fix may have occurred inthe minutes prior and the pump may have taken some time to bring thepressure down enough such that the pump duty cycle 6304 is below theleak threshold 6102.

The process 500 can implement hysteresis with clearing the detection orindication of leak. This can be performed to prevent false negatives.Upon detecting that the duty cycle is below the threshold 6102, theprocess 500 can decrement the counter. As illustrated, because counterof 10 directs the process 500 to initiate the leak alert, the processcan decrement the counter to 9. If the subsequent pump duty cycle 6306remains below the leak threshold 6102, the process 500 can cleardetection or indication of the leak. The process 500 can decrement thecounter to 8. The duration of time for clearing the leak can be shorterthan the duration of time for detecting the leak. For example, therespective durations illustrated in FIG. 6C are 10 minutes for detectingthe leak and 2 minutes for clearing the leak.

FIG. 6D is a diagram 6400 illustrating re-detection of a leak conditionaccording to some embodiments. In contrast with FIG. 6C, the leakcondition re-occurs in FIG. 6D. After leak is cleared with the pump dutycycle 6402 being below the leak threshold 6102, the process 500 cancontinue to monitor for a recurrence of a leak condition with knowledgeof the history of prior pump duty cycles. For example, the counter couldbe reset to 8 on the duty cycle 6402 as explained herein. Subsequentdetection of the pump duty cycles below the threshold 6102 can cause thecounter to be decremented further, for example, to 7 and 6 with the pumpduty cycle 6404. Such decrementing can continue until the leak counterreaches a number indicative of a normal operating condition, such as 0.

However, if a subsequent measured pump duty cycle, such as the dutycycle 6406, reverts back to indicating a leak condition (for example,exceeds the leak threshold 6102), the process 500 can increment the leakcounter 6406 again. As explained in connection with FIG. 6B, when thecounter reaches the threshold (such as, 10), the process 500 canreassert the leak indication. As is illustrated, this can occur when theprocess 500 detects that the pump duty cycle 6408 exceeds the leakthreshold 6102.

In some embodiments, the approach of FIGS. 6A-6D is advantageous as itprovides, based on the history of the leak condition detections, a moreresponsive leak detection, while also allowing for one or several dutycycles to be above the leak limit threshold 6102 without triggering theleak indication. A user attending to the leak indication can morereadily and quickly determine whether the fix provided a lasting fix.For example, the user may have fixed a visible leak to remove the leakindication, but the process 500 can detect other leaks that causereassertion of the leak indication.

Although FIGS. 6A-6D illustrate leak detection, blockage detection canbe similarly performed using the blockage threshold 6104. The process500 can detect pump duty cycles falling below the threshold 6104.

FIG. 7 illustrates a flowchart 700 of blockage and leak detection andindication according to some embodiments. The process 700 can beexecuted by one or more controllers of the TNP system, such as thesystem 100. The process 700 can be executed periodically, such as when ascheduled tick event 702 occurs, to monitor an occurrence of a blockageor leak condition. While the flowchart 700 provides all three aspects ofthe implementation in a single flowchart, including the calculation ofactivity 710 (illustrated as pump duty cycle), blockage detection 730,and leak detection 760, one or more of these can be independentlyimplemented in a separate flow chart.

At block 702, the process 700 detects a system tick event 702. The tickevent 702 can be based on one or more interrupts, clocks, or the like.The process 700 can address the tick event 702 by calling uponassociated functions interrupt handlers or functions, which can includethe pump duty cycle calculation 710.

The pump duty cycle calculation 710 can include blocks 712, 714, 716,718, and 720. At block 712, the process 700 can determine whether thenegative pressure source or pump is active or not. If the pump isdetermined to be in the active state, the process 700 can increment apump activity counter (for example, “onCount”) in block 714. Otherwise,the pump activity counter is not incremented.

In block 716, time duration is updated, such as incremented for eachobserved tick event. In some embodiments, the process 700 can delaycalculating the duty cycle until the time duration reaches a threshold(for example, “evalPeriod”), such as 1 minute. For example, assuming 10millisecond tick with 1 minute threshold, the process 700 can determinethat the threshold has been reached with 6,000 or more counts (10milliseconds*100*60 seconds=1 minute). In block 718, the process 700 cancompare the time duration against the threshold. If it is determinedthat the threshold has been reached, the process 700 can update the pumpduty cycle in block 720 as proportion of the pump activity counter(block 714) to the time duration (block 716) expressed as a percentage.Otherwise, the process 700 can determine that it is too early to performthe detection and transition to block 782 to end the process.

The process 700 can use the pump duty cycle determined in bloc 720 todetect or indicate a blockage or a leak in 730 or 760, respectively.Although FIG. 7 illustrates first performing the blockage detection 730followed by the leak detection 760, in some embodiments leak detectioncan precede blockage detection.

Blockage detection 730 can include blocks 732, 734, 736, 738, 740, 742,744, 746, and 748). In block 732, it can be determined if the pump dutycycle is below the blockage threshold (see, for example, 6104 in FIGS.6A-6D). For example, in the canister mode the blockage threshold can be0.5% duty cycle. If the process 700 determines that the pump duty cycleis below the blockage threshold, the process transition to block 734,where it can increment a blockage counter (for example, “B_total”) andblockage hysteresis counter (for example, “B_clamp”). The blockagehysteresis counter can have a ceiling value (for example, “MAX_B”)associated with blockage alert as described herein. For example, withreference to FIGS. 6A-6D, a blockage detection duration is 10 minutes.If the process 700 executes blockage detection 730 every minute, theblockage hysteresis counter can be set to 10. At block 734, bothcounters can increase up to 10 for each execution of blockage detection730, but from 10, only the blockage counter can increase to 11 orbeyond.

The process 700 can transition to block 736, where it can compare theblockage hysteresis counter against a blockage threshold counter (forexample, “B_set_threshold”) to determine whether a blockage conditionhas persisted long enough to activate blockage alert. If the blockagehysteresis counter exceeds blockage duration, sufficiently long time(for example, more than 10 minutes as in FIG. 6B) has passed with thepump duty cycle being below the blockage threshold. Blockage alert canbe activated as described herein. The process 700 can transition toblock 738 where it can set blockage alert (for example, “B_Flag”) totrue.

The process 700 can transition to block 740, where the blockage countercan be compared against a blockage threshold associated with stoppingtherapy (for example, “B_timeout”). This determination can be made toassess whether to stop the therapy because of the persisting blockagecondition. With reference to FIG. 6B, such blockage threshold can be 5minutes for addressing the blockage. If the comparison in block 740 istrue, the process 700 can transition to block 742 where it can indicatethat therapy should be stopped (for example, by setting “BlockTimeOut”to true). In some cases, the process 500 can transition the system intoTherapy Stop State 520.

In block 732, if the process 700 determines that the pump duty cycleexceeds the blockage limit threshold (for example, 6104), the process700 can transition to block 744. In block 744, the process 700 candecrement the blockage hysteresis counter (for example, “B_clamp”) andreset the block counter (for example, “B_total”) to the block hysteresiscounter. As described herein, the blockage hysteresis counter can beassociated with a ceiling value (for example, “MAX_B”). Decrementing theblockage hysteresis counter can result in a value less than the ceilingvalue. For example, with reference to FIG. 6C, after the detection of anormal pump duty cycle, the leak counter is reset to 9 (for example, 10decremented by 1). Similarly, the blockage counter can be reset to 9.

The process 700 can transition to block 746, wherein blockage hysteresiscounter can be compared against a blockage clear threshold (for example,“B_clear_threshold”) to determine whether to clear the blockage alert.The process 700 can require certain number of normal pump duty cyclesbefore clearing. For example, FIG. 6C illustrates at least 2 counts ofnormal duty cycle before clearing the leak alert. Similarly, the process700 can set the blockage hysteresis counter to 8. For example,decrementing block hysteresis counter of 10 will take two minutes beforeclearing the blockage alert in block 748. While a floor for the blockagehysteresis counter (for example, “B_clamp”) is not illustrated in FIG.7, in some embodiments, such floor can be used in order to not decreasethe blockage hysteresis counter indefinitely.

In some embodiments, leak detection can be performed similarly toblockage detection except that the process 700 can determine if the pumpduty cycle exceeds a leak threshold. Leak detection 760 can includeblocks 762, 764, 766, 768, 770, 772, 774, 776, and 778. In block 762,the process 700 can determine if the pump duty cycle determined in block720 is above the leak threshold (for example, 6102 in FIGS. 6A-6D). Forexample, in the canister mode, leak threshold of 12% can be used, and incanisterless mode, leak threshold of 4% can be used. If the process 700determines that the pump duty cycle is above the leak threshold, theprocess 700 can transition to block 764. The process 700 can increment aleak counter (for example, “L_total”) and a leak hysteresis counter (forexample, “L_clamp”). The leak hysteresis counter can have a ceilingvalue (for example, “MAX_L”) associated with leak alert as describedherein.

The process can transition to block 766, where it can compare the leakhysteresis counter against a leak threshold count (for example,“L_set_threshold”) to determine whether a leak condition has persistedlong enough to active a leak alert. If the leak hysteresis counterexceeds leak duration, sufficiently long time (for example, 10 minutesin FIG. 6B) has passed with the pump duty cycle being above the leakthreshold. Leak alert can be activated as described herein. The processcan transition to block 768 where it can set blockage alert (forexample, “L_Flag”) to true.

The process 700 can transition to block 770, where the leak counter canbe compared against a leak threshold associated with stopping therapy(for example, “L_timeout”). This determination can be made to assesswhether to stop the therapy because of the persisting leak condition.With reference to FIG. 6B, such leak threshold can be 5 minutes foraddressing the leak. If the comparison in block 770 is true, the process700 can transition to block 772 where it can indicate that therapyshould be stopped (for example, by setting “LeakTimeOut” to true). Insome cases, the process 500 can transition the system into Therapy StopState 520.

In block 762, if the process 700 determines that the pump duty does notexceed the leak threshold, such as 6102, the process 700 can transitionto block 774. In block 744, the process 700 can decrement the leakhysteresis counter (for example, “L_clamp”) and reset the leak counter(for example, “L_total”) to the leak hysteresis counter. As describedherein, the leak hysteresis counter can be associated with a ceilingvalue (for example, “MAX_L”). Decrementing the leak hysteresis countercan result in a value less than the ceiling value. For example, withreference to FIG. 6C, after the detection of a normal pump duty cycle,the leak counter is reset to 9 (for example, 10 decremented by 1).

The process can transition to block 776, wherein leak hysteresis countercan be compared against a leak clear threshold count (for example,“L_clear_threshold”) to determine whether to clear the leak alert. Theprocess 700 can require certain number of normal pump duty cycles beforeclearing. For example, FIG. 6C illustrates at least 2 counts of normalduty cycle before clearing the leak alert. Similarly, the process 700can set the leak hysteresis counter to 8. For example, decrementing leakhysteresis counter of 10 will take two minutes before clearing the leakalert in block 778. While a floor for the leak hysteresis counter (forexample, “L_clamp”) is not illustrated in FIG. 7, in some embodiments,such floor can be used in order to not decrease the leak hysteresiscounter indefinitely.

In some embodiments, the process 700 can reset the pump activity counter(for example, “onCount”) and the time duration (for example,“totalCount”) in block 780 before terminating. This can allows the pumpduty cycle calculation 710 to start with a clean set of variables forcalculation of the next pump duty cycle.

While illustrated leak detection 760 does not distinguish between asustainable leak and an unsustainable leak, in some embodiments, theprocess 700 can make such distinction. For example, leak detection 760can use a higher leak threshold (such as, at or close to 100% addescribed herein) for the detection of unsustainable leak.

Escalation of Alerts

FIGS. 8A and 8B illustrate escalation of blockage and leak alertsaccording to some embodiments. FIG. 8A illustrates escalation of leakalert in canister mode and canisterless mode (or canister-free mode).FIG. 8B illustrates escalation of a blockage alert in canister mode.

As described, a TNP system, such as the system 100, can detect asustainable leak 8102 or an unsustainable leak 8106 or 8108. Thisdetection can be performed by the process 500. For a sustainable leak, atarget pressure setpoint is attainable. In some cases, when at leastsome pump duty cycles exceed the leak threshold, such as the threshold6102, leak can be detected as described herein. Such sustainable leakmay occur as a result of a wound dressing that is not fully sealed.

In some embodiments, as described herein, when sustainable leak isdetected, the therapy may not have been fully compromised, and patientmay gain at least some benefits from continuing provision of therapy.The TNP system 100 or process 500 can provide a minor leak alert 8104 tobring the leak to user's attention, but continue to deliver negativepressure wound therapy. As illustrated, minor leak alert 8104 caninclude providing one or more of a visual indication or an audio alert.As described herein, visual indication can be provided via a leakindicator 8112 (which can correspond to the indicator 416). For example,the indicator can be turned amber. Audio indication can be provided byactivating a buzzer. Additional or alternative indications can beprovided as described herein.

In some implementations, over time, what started out as a sustainableleak may deteriorate into an unsustainable leak 8106. For example, asmall air leak due to a wound dressing that is not fully sealed maycontinue to get larger over time. Eventually, the negative pressuresource may be operating at or near its full capacity to attempt tomaintain the target pressure setpoint. As described herein, this can bedetected from the pump duty cycle being at or near 100%. When it isdetermined that the negative pressure source cannot achieve or maintainthe target pressure setpoint, it can be determined that therapy has beencompromised by the leak and the patient is no longer receiving benefitsfrom the therapy.

When a sustainable leak develops into an unsustainable leak, previousminor leak alert 8104 can be escalated to a major leak 8110. The TNPsystem 100 or process 500 can continue to alert the user, but turn offthe negative pressure source. In some cases, major leak alert 8110 usesdifferent indicators or different combination of indicators than theminor leak alert 8106 to distinguish the greater severity of the leakcondition. As described herein, for example, the leak indicator 8112(which can correspond to the indicator 416) can be amber and the on/offindicator 8114 (which can correspond to the indicator 418) can be green,respectively, for provision of the minor leak alert 8104, while bothindicators can be amber for provision of the major leak alert 8110.Audio alert can also be provided. Additional or alternative indicationscan be provided as described herein.

In some embodiments, an unsustainable leak can be detected directlywithout first detecting the minor leak alert. For example, this canoccur when the TNP system 100 is unable to achieve the target pressuresetpoint in the Pump Down State 516. The cause can be operating in thecanister mode without canister attached or operating in canisterlessmode without wound dressing attached. In such situations, the TNP system100 or process 500 can stop the therapy and provide the major leak alert8110 without first providing the minor leak alert 8104.

FIG. 8B illustrates escalation of a blockage alert in canister mode.Although not illustrated, the flow illustrated in FIG. 8B can beperformed in canisterless mode. In block 8202, the TNP system 100 orprocess 500 can detect blockage as described herein. For example, whenat least some pump duty cycles do not meet the blockage threshold, suchas the threshold 6104, blockage can be detected as described herein.Blockage can be caused by a full or substantially full canister orblockage in the fluid flow path.

In some embodiments, when blockage is detected, a minor blockage alert8204 is provided. The TNP system can continue delivery of negativepressure wound therapy as the patient may be receiving at least somebenefits. As illustrated, minor blockage alert 8204 can includeproviding one or more of a visual indication or an audio alert. Asdescribed herein, visual indication can be provided via a blockageindicator 8210 (which can correspond to the indicator 414). For example,the indicator can be turned amber. Audio indication can be provided byactivating a buzzer. Additional or alternatives indication can beprovided as described herein.

The TNP system 100 or process 500 can continue to monitor the blockage,for example via monitoring the duration of blockage. When it isdetermined that blockage is persistent 8206 (for example, lasts over anhour), it is likely that a patient is not gaining any benefits fromprovision of therapy.

When persistent blockage 8206 has been determined, in some embodiments,the TNP system or process 500 can escalate the blockage alert from theminor blockage alert 8204 to a major blockage alert 8208. In someimplementations, provision of therapy can be stopped. In some cases,major blockage alert 8208 uses different indicators or differentcombination of indicators than the minor blockage alert 8204 todistinguish the greater severity of the blockage condition. For example,the blockage indicator 8210 (which can correspond to the indicator 414)can be amber and the on/off indicator 8212 (which can correspond to theindicator 418) can be green, respectively, for provision of the minorblockage alert 8204, while both indicators can be amber for provision ofthe major blockage alert 8208. Audio alert can also be provided.Additional or alternative indications can be provided as describedherein.

Other Variations

Control systems and methods disclosed herein can be implemented by anyTNP system or any medical device. As used herein, stopping therapyencompasses suspending or pausing therapy. While certain colors ofindicators may be described in connection with various examples, anysuitable color can be additionally or alternatively used. Although thisdisclosure describes certain embodiments, it will be understood by thoseskilled in the art that many aspects of the methods and devices shownand described in the present disclosure may be differently combinedand/or modified to form still further embodiments or acceptableexamples. All such modifications and variations are intended to beincluded herein within the scope of this disclosure. Indeed, a widevariety of designs and approaches are possible and are within the scopeof this disclosure. No feature, structure, or step disclosed herein isessential or indispensable. Moreover, while illustrative embodimentshave been described herein, the scope of any and all embodiments havingequivalent elements, modifications, omissions, combinations (forexample, of aspects across various embodiments), substitutions,adaptations and/or alterations as would be appreciated by those in theart based on the present disclosure. While certain embodiments have beendescribed, these embodiments have been presented by way of example only,and are not intended to limit the scope of protection.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example described inthis section or elsewhere in this specification unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The protection is notrestricted to the details of any foregoing embodiments. The protectionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of protection. Indeed, the novel methods and systems describedherein may be embodied in a variety of other forms. Furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made. Those skilled in the art willappreciate that in some embodiments, the actual steps taken in theprocesses illustrated and/or disclosed may differ from those shown inthe figures. Depending on the embodiment, certain of the steps describedabove may be removed, others may be added. For example, the actual stepsand/or order of steps taken in the disclosed processes may differ fromthose shown in the figure. Depending on the embodiment, certain of thesteps described above may be removed, others may be added. For instance,the various components illustrated in the figures may be implemented assoftware and/or firmware on a processor, controller, ASIC, FPGA, and/ordedicated hardware. Hardware components, such as processors, ASICs,FPGAs, and the like, can include logic circuitry.

Furthermore, certain features that are described in this disclosure inthe context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations, one or more features from a claimedcombination can, in some cases, be excised from the combination, and thecombination may be claimed as a subcombination or variation of asubcombination.

Moreover, while operations may be depicted in the drawings or describedin the specification in a particular order, such operations need not beperformed in the particular order shown or in sequential order, or thatall operations be performed, to achieve desirable results. Otheroperations that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionaloperations can be performed before, after, simultaneously, or betweenany of the described operations. Further, the operations may berearranged or reordered in other implementations. Those skilled in theart will appreciate that in some embodiments, the actual steps taken inthe processes illustrated and/or disclosed may differ from those shownin the figures. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure. Also, theseparation of various system components in the implementations describedabove should not be understood as requiring such separation in allimplementations, and it should be understood that the describedcomponents and systems can generally be integrated together in a singleproduct or packaged into multiple products.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. Not necessarily all such advantages maybe achieved in accordance with any particular embodiment. Thus, forexample, those skilled in the art will recognize that the disclosure maybe embodied or carried out in a manner that achieves one advantage or agroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements, and/or steps areincluded or are to be performed in any particular embodiment. The terms“comprising,” “including,” “having,” and the like are synonymous and areused inclusively, in an open-ended fashion, and do not excludeadditional elements, features, acts, operations, and so forth. Also, theterm “or” is used in its inclusive sense (and not in its exclusivesense) so that when used, for example, to connect a list of elements,the term “or” means one, some, or all of the elements in the list.Further, the term “each,” as used herein, in addition to having itsordinary meaning, can mean any subset of a set of elements to which theterm “each” is applied.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than 10% of, within less than 5% of, within less than 1% of, withinless than 0.1% of, and within less than 0.01% of the stated amount. Asanother example, in certain embodiments, the terms “generally parallel”and “substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees,10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.

The scope of the present disclosure is not intended to be limited by thespecific disclosures of preferred embodiments in this section orelsewhere in this specification, and may be defined by claims aspresented in this section or elsewhere in this specification or aspresented in the future. The language of the claims is to be interpretedbroadly based on the language employed in the claims and not limited tothe examples described in the present specification or during theprosecution of the application, which examples are to be construed asnon-exclusive.

1. A negative pressure wound therapy apparatus comprising: a negativepressure source configured to provide negative pressure to a wound via afluid flow path comprising a wound dressing positioned over the wound;and a controller configured to operate the negative pressure source toprovide negative pressure to the wound when the negative pressure sourceis fluidically connected to the wound dressing directly or when thenegative pressure source is fluidically connected to the wound dressingvia a canister configured to store at least some fluid aspirated fromthe wound by the negative pressure source, the controller furtherconfigured to: in response to determining that the negative pressuresource is directly fluidically connected to the wound dressing, operatethe negative pressure source in a first mode to provide negativepressure to the wound; in response to determining that the negativepressure source is fluidically connected to the wound dressing via thecanister, operate the negative pressure source in a second mode toprovide negative pressure to the wound, the second mode being differentfrom the first mode; determine a level of activity of the negativepressure source; in response to determining that the level of activityof the negative pressure source over a first duration of time satisfiesat least one of a leak condition or a blockage condition, provide afirst indication of at least one of a leak or a blockage in the fluidflow path after expiration of the first duration of time; and inresponse to determining that the level of activity of the negativepressure source does not satisfy the at least one of the leak conditionor the blockage condition over a second duration of time subsequent tothe first duration of time, discontinue provision of the firstindication of the at least one of the leak or the blockage in the fluidflow path after expiration of the second duration of time, wherein thesecond duration of time is shorter than the first duration of time. 2.(canceled)
 3. The apparatus of claim 1, wherein the level of activity ofthe negative pressure source comprises duty cycle of the negativepressure source.
 4. The apparatus of claim 3, wherein: the at least oneof the leak condition or the blockage condition comprises a first dutycycle threshold in the first mode and a second duty cycle threshold inthe second mode, the first duty cycle threshold different from thesecond duty cycle threshold; and the controller is further configured tocompare the level of activity over the first and second durations oftime to one of the first or second duty cycle thresholds.
 5. Theapparatus of claim 4, wherein the first duty cycle threshold is greaterthan the second duty cycle threshold.
 6. The apparatus of claim 1,wherein the controller is further configured to: provide the firstindication of the at least one of the leak or blockage in the fluid flowpath without deactivating the negative pressure source; and in responseto determining that the level of activity of the negative pressuresource continues to satisfy the at least one of the leak condition orthe blockage condition over a third duration of time subsequent to thefirst duration of time, deactivate the negative pressure source afterexpiration of the third duration of time.
 7. The apparatus of claim 6,wherein the controller is further configured to provide a secondindication different from the first indication after expiration of thethird duration of time.
 8. The apparatus of claim 7, wherein the firstindication comprises a visual indication of a first color and the secondindication comprises a visual indication of a second color differentfrom the first color.
 9. The apparatus of claim 6, wherein the thirdduration of time is subsequent to the second duration of time.
 10. Amethod of operating a negative pressure wound therapy device comprisinga negative pressure source and a controller, the method comprising, bythe controller: operating the negative pressure source configured toprovide negative pressure to a wound via a fluid flow path comprising awound dressing positioned over the wound when the negative pressuresource is fluidically connected to the wound dressing directly or whenthe negative pressure source is fluidically connected to the wounddressing via a canister configured to store at least some fluidaspirated from the wound by the negative pressure source; in response todetermining that the negative pressure source is directly fluidicallyconnected to the wound dressing, operating the negative pressure sourcein a first mode to provide negative pressure to the wound; in responseto determining that the negative pressure source is fluidicallyconnected to the wound dressing via the canister, operating the negativepressure source in a second mode to provide negative pressure to thewound, the second mode being different from the first mode; determininga level of activity of the negative pressure source; in response todetermining that the level of activity of the negative pressure sourceover a first duration of time satisfies at least one of a leak conditionor a blockage condition, providing a first indication of at least one ofa leak or a blockage in the fluid flow path after expiration of thefirst duration of time without deactivating the negative pressuresource; in response to determining that the level of activity of thenegative pressure source does not satisfy the at least one of the leakcondition or the blockage condition over a second duration of timesubsequent to the first duration of time, discontinuing provision of thefirst indication of the at least one of the leak or the blockage in thefluid flow path after expiration of the second duration of time; and inresponse to determining that the level of activity of the negativepressure source continues to satisfy the at least one of the leakcondition or the blockage condition over a third duration of timesubsequent to the first duration of time, deactivating the negativepressure source after expiration of the third duration of time.
 11. Themethod of claim 10, wherein the second duration of time is shorter thanthe first duration of time.
 12. The method of claim 10, wherein thelevel of activity of the negative pressure source comprises duty cycleof the negative pressure source.
 13. The method of claim 12, wherein:the at least one of the leak condition or the blockage conditioncomprises a first duty cycle threshold in the first mode and a secondduty cycle threshold in the second mode, the first duty cycle thresholddifferent from the second duty cycle threshold; and the method furthercomprises, by the controller, comparing the level of activity over thefirst and second durations of time to one of the first or second dutycycle thresholds.
 14. The method of claim 13, wherein the first dutycycle threshold is greater than the second duty cycle threshold. 15.(canceled)
 16. The method of claim 11, further comprising, by thecontroller, providing a second indication different from the firstindication after expiration of the third duration of time.
 17. Themethod of claim 16, wherein the first indication comprises a visualindication of a first color and the second indication comprises a visualindication of a second color different from the first color.
 18. Themethod of claim 11, wherein the third duration of time is subsequent tothe second duration of time.